OTC Medication Information: ASPIRIN 325 MG EC

ASPIRIN 325 MG EC- aspirin tablet
Proficient Rx LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Aspirin USP, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain Reliever/Fever Reducer

temporarily relieves

headache
menstrual pain
minor pain of arthritis
muscle pain
toothache
pain and fever of colds

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this prodcut, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include

hives
facial swelling
asthma (wheezing)
shock

Stomach bleeding warning: This prodcut contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, or others)
take more or for a longer time than directed
have 3 or more alcoholic drinks every day while using this product

Drug Facts continued on back of label

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis
under a doctor’s care for any serious condition
taking any other drug

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

• feel faint

• vomit blood

• have bloody or black stools

• have stomach pain that does not get better

pain gets worse or lasts more than 10 days
fever gets worse or lasta more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
ringing in the ears or loss of hearing occurs

These could be sings of a serious condition

If pregnant or breast-feeding, ask a health professional before use. It is especially imporant not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
children under 12 years: ask a doctor

Other information

store at room temperature 15°-30ºC (59°-86°F)

Inactive ingredients

croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or comments?

Questions or comments ? call 516-341-0666, 8:30 am — 4:30 pm ET, Monday — Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320

www.reliable1labs.com

71205-318-60
(click image for full-size original)
NDC 71205-318-60

Enteric Coated

Aspirin USP 325 mg (NSAID)

PAIN RELIEVER

FEVER REDUCER

60 TABLETS

*Compare to Active Ingredients in Ecotrin®

ASPIRIN 325 MG EC
aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-318(NDC:69618-015)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
METHACRYLIC ACID
STEARIC ACID
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
PROPYLENE GLYCOL
TITANIUM DIOXIDE
TALC
SODIUM LAURYL SULFATE
POLYETHYLENE GLYCOL 1000
Product Characteristics
Color orange Score no score
Shape ROUND Size 10mm
Flavor Imprint Code AP;110
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-318-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:71205-318-60 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:71205-318-90 90 TABLET in 1 BOTTLE, PLASTIC None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 11/01/2015
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-318), RELABEL (71205-318)

Revised: 01/2021 Proficient Rx LP

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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